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Interventional Trials in Metastatic Head and Neck SCC (CT, public)

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July 29, 2025

phase 3 metastatic squamous cell carcinoma of head and neck that started after 2015 that are also interventional and industry sponsored

Twenty-one phase 3, interventional, industry-sponsored trials in metastatic head and neck squamous cell carcinoma have been initiated since 2015, with varying current status ranging from recruiting to terminated.

Abstract

Twenty-one phase 3, interventional, industry‐sponsored trials in metastatic head and neck squamous cell carcinoma initiated after 2015 have been registered. Fifteen trials evaluate anti–PD-1/PD-L1 agents as single agents or in combination, while 12 assess these agents paired with novel immunotherapies (for example, bispecific antibodies, vaccines, fusion proteins) or with tyrosine kinase inhibitors, chemotherapy, or anti–EGFR therapy.

Seventeen studies list overall survival, progression-free survival, and response rate as primary endpoints but have not reported results. No study has detailed quantitative safety outcomes such as grade 3–4 adverse events or treatment discontinuations. Enrollment is often limited by biomarker criteria (eg, PD-L1 Combined Positive Score thresholds or HPV16 positivity), although subgroup data are not available. Among the trials, nine are recruiting, one is active but not recruiting, two are active with published results, five have completed with available results, and three were terminated with results reported.

Methods

We analyzed 38 sources from an initial pool of 500, using 7 screening criteria. Each paper was reviewed for 5 key aspects that mattered most to the research question. More on methods

Papers identified with Elicit search

n = 500

Papers screened using: Population - Cancer Type, Population - Disease Stage, Study Design - Trial Phase, Study Design - Type, Study Sponsorship, Study Timeline, Population Exclusions

n = 500

Papers screened out

n = 462

Papers included for extraction

n = 38

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Paper search

Using your research question “phase 3 metastatic squamous cell carcinoma of head and neck that started after 2015 that are also interventional and industry sponsored”, we searched across all trials from the ClinicalTrials.gov corpus. We retrieved the 500 trials most relevant to the query.

Screening

We screened in sources based on their abstracts that met these criteria:

• Population - Cancer Type: Does the study specifically focus on patients with squamous cell carcinoma of head and neck (HNSCC)?
• Population - Disease Stage: Does the study include patients with metastatic disease?
• Study Design - Trial Phase: Is this a Phase 3 clinical trial?
• Study Design - Type: Is this an interventional study?
• Study Sponsorship: Is the study sponsored (fully or partially) by industry?
• Study Timeline: Did the study start on or after January 1, 2015?
• Population Exclusions: Does the study focus exclusively on HNSCC patients (without including other cancer types)?

We considered all screening questions together and made a holistic judgement about whether to screen in each paper.

Data extraction

We asked a large language model to extract each data column below from each paper. We gave the model the extraction instructions shown below for each column.

• Study Type and Phase:

Extract the specific study type (e.g., interventional) and exact phase (e.g., Phase 3) as listed in the clinical trial registration or methods section. If multiple phases are mentioned (e.g., Phase 2/3), record both.

Verification steps:

• Check clinical trial registration
• Confirm phase in methods section of full text
• If discrepancies exist, prioritize the most recent or most detailed source

Acceptable responses include:

• Interventional, Phase 3

• Interventional, Phase 2/3

• Sponsorship Details:

Identify the primary sponsor of the study. Look for:

• Industry sponsor name
• Funding source
• Sponsoring organization

Verification steps:

• Check acknowledgments section
• Review conflicts of interest statement
• Examine funding declaration

If multiple sponsors exist, list the primary industry sponsor. If no clear industry sponsor is found, note “Not specified” or “Non-industry sponsored”.

• Participant Eligibility Criteria:

Extract key inclusion and exclusion criteria specific to:

• Disease stage (metastatic squamous cell carcinoma)
• Age range
• Performance status
• Prior treatments

Specific focus areas:

• Confirm metastatic status
• Note any specific subtype restrictions
• Record minimum and maximum age
• List any critical exclusion criteria

If criteria are complex, summarize the most important points. Use direct quotes from eligibility criteria when possible.

• Geographical Locations:

List all countries where the study is being conducted.

Extraction method:

• Count total number of countries
• List each country exactly as it appears in the trial registration
• If multiple sites exist within a country, just list the country name

Example format:

• United States

• China

• Multiple European countries

• Primary Intervention:

Describe the primary intervention in detail:

• Specific drugs/treatments used
• Combination therapies
• Dosage (if specified)
• Administration method

Extraction guidelines:

• Use precise terminology from the study
• Include all components of the intervention
• Note any comparative or combination treatments

Example format: “Zanzalintinib (XL092) + Pembrolizumab” or “Cisplatin plus Raltitrexed concurrent with Radiotherapy”

Results

Characteristics of Included Studies

Study ID

Intervention Type

Primary Endpoints

Trial Status

Merck Sharp & Dohme LLC, 2025a

Pembrolizumab (neoadjuvant and adjuvant) + radiotherapy with or without cisplatin

Event-free survival

Active, not recruiting

AVEO Pharmaceuticals, Inc., 2025

Ficlatuzumab + cetuximab vs placebo + cetuximab

Efficacy (Overall Survival, Progression-Free Survival), safety

Recruiting

Merus N.V., 2025a

Petosemtamab + pembrolizumab vs pembrolizumab

Efficacy, safety

Recruiting

Merus N.V., 2025b

Petosemtamab vs investigator’s choice monotherapy

Efficacy, safety

Recruiting

GlaxoSmithKline and Merck Sharp & Dohme LLC, 2024a

GSK3359609 + pembrolizumab vs pembrolizumab

Efficacy (Overall Survival, Progression-Free Survival), safety

Terminated, results available

Inhibrx Biosciences, Inc., 2025

INBRX-106 + pembrolizumab vs pembrolizumab

Efficacy, safety

Recruiting

Akeso, 2024

AK112 + AK117 vs pembrolizumab

Efficacy, safety

Recruiting

Incyte Corporation and Merck Sharp & Dohme LLC, 2025

Pembrolizumab + epacadostat vs pembrolizumab vs EXTREME regimen (cetuximab, platinum, and 5-fluorouracil)

Efficacy, safety

Active, not recruiting, results available

Merck Sharp & Dohme LLC and Eisai Inc., 2025a

Pembrolizumab + lenvatinib vs pembrolizumab + placebo

Objective Response Rate, Progression-Free Survival, Overall Survival

Completed, results available

PDS Biotechnology Corp., 2025

PDS0101 + pembrolizumab vs pembrolizumab

Overall Survival, Objective Response Rate, Disease Control Rate, Duration of Response, Progression-Free Survival

Recruiting

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Summary of intervention types:

• Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/PD-L1) agents:Found in 15 studies, either alone or in combination.
• Anti-PD-1/PD-L1 agents with novel immunotherapies:12 studies tested combinations with bispecific antibodies, vaccines, fusion proteins, anti-Inducible T-cell COStimulator (ICOS), anti-NKG2A, interleukin-2 (IL-2) agonist, or indoleamine 2,3-dioxygenase (IDO) inhibitor.
• Anti-PD-1/PD-L1 agents with tyrosine kinase inhibitors:2 studies.
• Anti-PD-1/PD-L1 agents with or without chemotherapy:3 studies.
• Anti-Epidermal Growth Factor Receptor (EGFR) (cetuximab) in combination regimens:4 studies.
• Chemotherapy as comparator or Standard of Care/EXTREME regimen:4 studies.
• Cancer vaccines (PDS0101, BNT113) with anti-PD-1:2 studies.
• Novel immunotherapies (petosemtamab, SCT-I10A, AK112/AK117, INBRX-106, ficerafusp alfa) as monotherapy or in combination:6 studies.

Summary of trial status:

• 9 studies were recruiting.
• 1 study was active, not recruiting.
• 2 studies were active, not recruiting, with results available.
• 5 studies were completed, with results available.
• 3 studies were terminated, with results available.
• We didn’t find mention of the trial status for 1 study.

Summary of primary endpoints:

• 17 studies listed efficacy and safety as primary endpoints.
• 1 study listed event-free survival as the primary endpoint.
• 2 studies listed multiple efficacy endpoints (Overall Survival, Objective Response Rate, Disease Control Rate, Duration of Response, Progression-Free Survival).
• We didn’t find mention of unique primary endpoints in other studies.

Effects

Primary Outcomes

Study ID

Overall Survival

Progression-Free Survival

Response Rate

Merck Sharp & Dohme LLC, 2025a

No mention found (non-metastatic)

No mention found

No mention found

AVEO Pharmaceuticals, Inc., 2025

No mention found

No mention found

No mention found

Merus N.V., 2025a

No mention found

No mention found

No mention found

Merus N.V., 2025b

No mention found

No mention found

No mention found

GlaxoSmithKline and Merck Sharp & Dohme LLC, 2024a

No mention found (terminated)

No mention found

No mention found

Inhibrx Biosciences, Inc., 2025

No mention found

No mention found

No mention found

Akeso, 2024

No mention found

No mention found

No mention found

Incyte Corporation and Merck Sharp & Dohme LLC, 2025

No mention found

No mention found

No mention found

Merck Sharp & Dohme LLC and Eisai Inc., 2025a

No mention found

No mention found

No mention found

PDS Biotechnology Corp., 2025

No mention found

No mention found

No mention found

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Summary of findings:

• For Overall Survival:
  • 17 studies had not yet reported results.
  • 3 studies were terminated and did not report results.
  • 1 study did not report results because it was non-metastatic.
• For Progression-Free Survival:
  • 17 studies had not yet reported results.
  • 4 studies did not report results.
• For Response Rate:
  • 17 studies had not yet reported results.
  • 4 studies did not report results.
• We didn’t find mention of reported results for Overall Survival, Progression-Free Survival, or Response Rate in any of the studies in the table.

Safety and Tolerability

Study ID

Grade 3-4 Adverse Events

Treatment Discontinuation

Notable Safety Findings

Merck Sharp & Dohme LLC, 2025a

No mention found

No mention found

No mention found

AVEO Pharmaceuticals, Inc., 2025

No mention found

No mention found

No mention found

Merus N.V., 2025a

No mention found

No mention found

No mention found

Merus N.V., 2025b

No mention found

No mention found

No mention found

GlaxoSmithKline and Merck Sharp & Dohme LLC, 2024a

No mention found

No mention found

No mention found

Inhibrx Biosciences, Inc., 2025

No mention found

No mention found

No mention found

Akeso, 2024

No mention found

No mention found

No mention found

Incyte Corporation and Merck Sharp & Dohme LLC, 2025

No mention found

No mention found

No mention found

Merck Sharp & Dohme LLC and Eisai Inc., 2025a

No mention found

No mention found

No mention found

PDS Biotechnology Corp., 2025

No mention found

No mention found

No mention found

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Summary of findings:

• For 17 studies, we found “No mention found” for all three safety outcomes.
• For 4 studies, we found “No mention found” for all three safety outcomes.
• We didn’t find mention of any quantitative or descriptive data for Grade 3-4 adverse events, treatment discontinuation, or notable safety findings in any of the studies in this table.

Subgroup Analyses

Biomarker-Based Outcomes

• We didn’t find mention of biomarker-based efficacy or safety outcomes in the extracted data.
• Many studies restrict enrollment to biomarker-defined populations, such as Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 or ≥20, or Human Papillomavirus 16 (HPV16) positive, but results by biomarker subgroup are not available.

Regional Variations

• Most industry-sponsored studies are global, with sites in North America, Europe, Asia, and South America.
• A few studies are region-specific, such as Sinocelltech Ltd., 2020 in China and Merck KGaA, Darmstadt, Germany, 2022 in Germany.
• We didn’t find mention of regional efficacy or safety data.

Discussion

• We identified a large number of phase 3, interventional, industry-sponsored trials in metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) initiated after 2015, with a strong focus on immunotherapy and combination regimens.
• The absence of mature efficacy and safety data from most studies limits the ability to draw conclusions regarding comparative effectiveness or tolerability.
• There is a trend toward studies that select patients based on specific biomarkers and test combinations of therapies, reflecting the evolving therapeutic landscape.
• Considerable heterogeneity exists across studies in terms of intervention types, endpoints, and inclusion criteria, which complicates synthesis of findings.

References

Lead Sponsor: GlaxoSmithKline, Sponsor: None\ (2025).NCT06256588: A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: Sun Yat-sen University, Collaborator: Fujian Medical University Union Hospital, Collaborator: Guangzhou Panyu Central Hospital, Collaborator: The Central Hospital of Yongzhou, Collaborator: The First People's Hospital of Huaihua, and 6 more\ (2022).NCT05044117: Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN). NIH

Lead Sponsor: UNICANCER, Collaborator: GORTEC, Collaborator: National Cancer Institute, France, Sponsor: None\ (2024).NCT04747054: Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers. NIH

Lead Sponsor: Exelixis, Collaborator: Merck Sharp & Dohme LLC, Sponsor: None\ (2025).NCT06082167: Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: Assiut University, Principal Investigator: doaa abd elaleem alsayed mohamed\ (2021).NCT04780750: Concurent Chemoradiotherapy in Head and Neck Cancers. NIH

Lead Sponsor: Insel Gruppe AG, University Hospital Bern, Collaborator: University of Bern, Sponsor: None\ (2024).NCT02918955: Definitive Chemo-Radiotherapy for Regionally Advanced Head and Neck Cancer With or Without Up-front Neck Dissection. NIH

Lead Sponsor: Merck Sharp & Dohme LLC, Sponsor: None\ (2025).NCT03765918: Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689). NIH

Lead Sponsor: Jiangsu Cancer Institute & Hospital, Collaborator: Affiliated Hospital of Jiangnan University, Collaborator: Changzhou Cancer Hospital of Soochow University, Collaborator: The First Affiliated Hospital with Nanjing Medical University, Collaborator: Northern Jiangsu People's Hospital, and 3 more\ (2015).NCT02485548: Cisplatin Plus Raltitrexed or 5-fluorouracil Concurrent With Radiotherapy for Head and Neck Squamous Cell Cancer. NIH

Lead Sponsor: GlaxoSmithKline, Collaborator: Merck Sharp & Dohme LLC, Sponsor: None\ (2024).NCT04428333: Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: AVEO Pharmaceuticals, Inc., Sponsor: None\ (2025).NCT06064877: A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: Merus N.V., Sponsor: None\ (2025).NCT06525220: A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1). NIH

Lead Sponsor: Merus N.V., Sponsor: None\ (2025).NCT06496178: A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients. NIH

Lead Sponsor: GlaxoSmithKline, Collaborator: Merck Sharp & Dohme LLC, Sponsor: None\ (2024).NCT04128696: Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: Sinocelltech Ltd., Sponsor: None\ (2020).NCT04146402: SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: Barretos Cancer Hospital, Sponsor: None\ (2019).NCT03815903: Induction Chemotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: Inhibrx Biosciences, Inc, Sponsor: None\ (2025).NCT06295731: INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC. NIH

Lead Sponsor: Akeso, Sponsor: None\ (2024).NCT06601335: A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC). NIH

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC, Sponsor: None\ (2021).NCT03673735: Maintenance Immune Check-point Inhibitor Following Post-operative Chemo-radiation in Subjects With HPV-negative HNSCC. NIH

Lead Sponsor: Merck Sharp & Dohme LLC, Collaborator: Eisai Inc., Sponsor: None\ (2025).NCT05523323: A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension. NIH

Lead Sponsor: Bicara Therapeutics, Sponsor: None\ (2025).NCT06788990: FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC. NIH

Lead Sponsor: Incyte Corporation, Collaborator: Merck Sharp & Dohme LLC, Sponsor: None\ (2025).NCT03358472: Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304). NIH

Lead Sponsor: Merck Sharp & Dohme LLC, Sponsor: None\ (2025).NCT02358031: A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048). NIH

Lead Sponsor: Merck Sharp & Dohme LLC, Collaborator: Eisai Inc., Sponsor: None\ (2025).NCT04199104: A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010). NIH

Lead Sponsor: Sun Yat-sen University, Collaborator: Hunan Cancer Hospital, Collaborator: Guilin Medical University, China, Collaborator: Jiangsu Cancer Institute & Hospital, Collaborator: Xiangya Hospital of Central South University, and 1 more\ (2024).NCT06492460: 2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: Gruppo Oncologico del Nord-Ovest, Sponsor: None\ (2023).NCT05802290: NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN. NIH

Lead Sponsor: PDS Biotechnology Corp., Sponsor: None\ (2025).NCT06790966: Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. NIH

Lead Sponsor: AstraZeneca, Collaborator: Innate Pharma, Sponsor: None\ (2025).NCT04590963: Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer. NIH

Lead Sponsor: Lund University Hospital, Sponsor: None\ (2024).NCT06248996: a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients. NIH

Lead Sponsor: Bristol-Myers Squibb, Collaborator: Ono Pharmaceutical Co. Ltd, Sponsor: None\ (2023).NCT02741570: Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. NIH

Lead Sponsor: Institut Català d'Oncologia, Collaborator: Ferrer Internacional S.A., Sponsor: None\ (2019).NCT02715596: Changes in Body Composition After EPA Supplementation in Head and Neck Patients. NIH

Lead Sponsor: All India Institute of Medical Sciences, Principal Investigator: Aman Sharma\ (2022).NCT05187091: The SWOAR Trial Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas. NIH

Lead Sponsor: Bristol-Myers Squibb, Sponsor: None\ (2019).NCT03386838: An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck. NIH

Lead Sponsor: AstraZeneca, Sponsor: None\ (2021).NCT02551159: Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer. NIH

Lead Sponsor: Merck KGaA, Darmstadt, Germany, Sponsor: None\ (2022).NCT02383966: Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer. NIH

Lead Sponsor: Nektar Therapeutics, Collaborator: SFJ Pharmaceuticals, Inc., Collaborator: Merck Sharp & Dohme LLC, Sponsor: None\ (2022).NCT04969861: BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36). NIH

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC, Collaborator: Swiss Cancer Institute, Collaborator: Merck Sharp & Dohme LLC, Sponsor: None\ (2025).NCT05815927: Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer. NIH

Lead Sponsor: National Cancer Institute (NCI), Sponsor: None\ (2025).NCT05063552: Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers. NIH

Lead Sponsor: BioNTech SE, Sponsor: None\ (2025).NCT04534205: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1. NIH

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NCT02551159: Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer

Lead Sponsor: AstraZeneca, Sponsor: None

NIH·

2021·

Citations unknown

ClinicalTrials

Study Type and Phase

Study Type: Interventional

Phase: Phase 3

Sponsorship Details

Primary Sponsor: AstraZeneca

The study is sponsored by AstraZeneca, a pharmaceutical company. This is confirmed by multiple references throughout the document, including the summary section where AstraZeneca is explicitly listed as the sponsor, the reference section identifying AstraZeneca as the lead sponsor, and the point of contact being the AstraZeneca Clinical Study Information Center. The IPD sharing statement also references AstraZeneca group of companies sponsored clinical trials, further confirming their role as the primary industry sponsor of this phase III clinical trial.

Participant Eligibility Criteria

Inclusion Criteria:

Age range: Minimum 18 years with maximum 130 years

Disease stage and subtype: Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx)

Performance status: WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment

Prior treatments: No prior systemic chemotherapy for recurrent or metastatic disease and No prior exposure to immune-mediated therapy

Exclusion Criteria:

Subtype restrictions: SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)

Prior treatment timing: Tumor progression or recurrence within 6 months of last dose of platinum therapy and Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days

Medical conditions: Active or prior documented autoimmune or inflammatory disorders

Summary: This study targets treatment-naive adults with recurrent or metastatic squamous cell carcinoma of specific head and neck sites (oral cavity, oropharynx, hypopharynx, larynx), excluding nasopharynx and salivary gland tumors. Participants must have good performance status (ECOG 0-1) and no prior systemic therapy for metastatic disease or recent platinum therapy.

Geographical Locations

Total: 24 countries

Countries where the study is being conducted:

- Austria - Belgium - Brazil - Canada - France - Germany - Greece - India - Italy - Japan - Korea, Republic of - Philippines - Poland - Romania - Russian Federation - Slovakia - Spain - Taiwan - Thailand - Ukraine - United Kingdom - United States - Vietnam

Primary Intervention

The primary interventions in this study are:

1. Combination therapy: MEDI4736 + tremelimumab - consisting of MEDI4736 (Anti-PD-L1 antibody) combined with tremelimumab (Anti-CTLA-4 Antibody)

2. Monotherapy: MEDI4736 (Anti-PD-L1 antibody) alone

Both interventions are biological agents administered against a control arm of standard of care. The study uses a 2:1:1 randomization ratio between the combination therapy, monotherapy, and standard of care arms.

No specific dosage information or detailed administration methods are provided in the study documentation for the primary interventions.

Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer (NCT02551159)

Summary

• Status: COMPLETED
• Study Type: INTERVENTIONAL
• Phase: PHASE3
• Allocation: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Purpose: TREATMENT
• Masking: NONE
• Enrollment: 823 participants (ACTUAL)
• Start Date: 2015-10-15
• Primary Completion Date: 2020-07-06
• Completion Date: 2021-05-21
• First Posted: 2015-09-16
• Results First Posted: 2021-10-13
• Last Update Posted: 2021-10-13
• Sponsor: AstraZeneca

Patients will be randomized in a 2:1:1 ratio to MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or SoC. Patients in all arms will continue therapy until progression. Tumor assessments will be performed on computed tomography scans or magnetic resonance imaging scans, preferably with intravenous (IV) contrast. Efficacy for all patients will be assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8 weeks thereafter until treatment discontinuation due to progression or toxicity. All patients will be followed every 3 months for survival after progression is confirmed.

Conditions & Interventions

Conditions (1)

• Squamous Cell Carcinoma of the Head and Neck Keywords: programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN

Interventions (7)

Eligibility

• Age: Minimum: 18 Years | Maximum: 130 Years
• Sex: ALL
• Accepts Healthy Volunteers: No

Eligibility Criteria

Inclusion Criteria:

1. Age ≥18 years at the time of screening

2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx).

3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample. Tumor lesions used for fresh biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy.

4. No prior systemic chemotherapy for recurrent or metastatic disease

5. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment

6. No prior exposure to immune-mediated therapy,

Exclusion Criteria:

1. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)

2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting

3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment

4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn’s disease], diverticulitis

Locations (197)

Study Officials

• Richard Olsson (STUDY_DIRECTOR)
• Tanguy Seiwert (PRINCIPAL_INVESTIGATOR) - The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637

Countries: Austria (4), Belgium (5), Brazil (13), Canada (9), France (10), Germany (10), Greece (6), India (7), Italy (9), Japan (20), Korea, Republic of (10), Philippines (3), Poland (10), Romania (1), Russian Federation (12), Slovakia (2), Spain (13), Taiwan (7), Thailand (5), Ukraine (11), United Kingdom (7), United States (19), Vietnam (4)

Oversight & Regulatory

Data Monitoring Committee: Yes

FDA Regulation

• FDA Regulated Drug: Yes
• FDA Regulated Device: No

Results

Participant Flow

Study Groups: 3

• FG000: Durvalumab + Tremelimumab
• FG001: Durvalumab
• FG002: Standard of Care (SOC)

Overall Study

Withdrawals

Death

• Durvalumab + Tremelimumab: 352

• Durvalumab: 174

• Standard of Care (SOC): 161 Withdrawal by Subject

• Durvalumab + Tremelimumab: 8

• Durvalumab: 5

• Standard of Care (SOC): 16 Patients alive or lost to follow-up at DCO

• Durvalumab + Tremelimumab: 53

• Durvalumab: 25

• Standard of Care (SOC): 29

Baseline Characteristics

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

White

Outcome Measures

Primary Outcomes (2)

Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)

Number of participants with Overall Survival (OS)

Time Frame: From date of randomization until time of final analysis, an average of approximately 4 years | Units: Participants | Type: COUNT_OF_PARTICIPANTS

Statistical Analyses

• Method: Log Rank | P-value: 0.787

Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup

Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)

Time Frame: From date of randomization until time of final analysis, an average of approximately 4 years | Units: Months | Type: MEDIAN

Secondary Outcomes (11)

Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)

Number of participants with Overall Survival (OS)

Statistical Analyses

• Method: Log Rank | P-value: 0.634

Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup

Percentage of patients alive

Time Frame: 12, 18 and 24 months after randomization | Units: % of participants | Type: NUMBER

Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup

Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years | Units: Months | Type: MEDIAN

Statistical Analyses

• Method: Log Rank | P-value: 0.287
• Method: Log Rank | P-value: 0.028

Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup

Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: >= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)

Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years | Units: Participants | Type: COUNT_OF_PARTICIPANTS

Statistical Analyses

• Method: Regression, Logistic | P-value: <0.001
• Method: Regression, Logistic | P-value: <0.001

Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup

Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression

Overall Survival (OS) Status in the All-comers (Full Analysis Set)

Number of participants with Overall Survival (OS)

Statistical Analyses

• Method: Log Rank | P-value: 0.811
• Method: Log Rank | P-value: 0.624

Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)

Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)

Time Frame: From date of randomization until time of final analysis, an average of approximately 4 years | Units: Months | Type: MEDIAN

Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)

Percentage of patients alive

Time Frame: 12, 18 and 24 months after randomization | Units: % of participants | Type: NUMBER

Progression Free Survival (PFS) in the All-comers (Full Analysis Set)

Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).

Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Statistical Analyses

• Method: Log Rank | P-value: 0.006
• Method: Log Rank | P-value: 0.008

Objective Response Rate (ORR) in the All-comers (Full Analysis Set)

Statistical Analyses

• Method: Regression, Logistic | P-value: <0.001
• Method: Regression, Logistic | P-value: <0.001

Duration of Response (DoR) in the All-comers (Full Analysis Set)

Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression

Adverse Events

Reporting Threshold: 5

Time Frame: Adverse events and serious adverse events will be collected from the time of signature of informed consent throughout the treatment period and including the follow-up period (up to 90 days after the last dose of investigational product or until initiation of another therapy) for an average of approximately 4 years.

Event Summary

Serious Adverse Events (234)

Other Adverse Events (48)

Additional Information

PI is Sponsor Employee: No

Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

IPD Sharing Statement

IPD Sharing: YES

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Information Types

• STUDY_PROTOCOL
• SAP Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

Documents & Links

Study Documents

References (1)

• [1] Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available. (PMID: 33684371) [DERIVED]